Life is experienced when you step out of your comfort zone. I chose over 13 years ago to do that (in the hope of making a positive change to the network). Transitioning from studying Pharmacology to writing dossiers and launching medicinal products on the market provided the foundations for my next move. The sideways step into technology was met with nervous excitement and a world full of acronyms (what are eCTD and PIM?). Early on, I joined Telematics meetings with the EMA and NCA, questioning why I was there. I was inspired by how people spoke passionately about the future but left confused about how everything connected together.
Upon reflection on my early years, I soon realized I didn’t understand where we were going. My curiosity set in, and it was time to get involved.
The EMA and HMA have a joint telematics organization, the EU Telematics Management Board.
The task forces and working groups are operational, feeding information strategically. You can find more information here.
Over the years, my ability to understand how the telematics ecosystem functioned provided me with significant advantages. As a member of Medicines for EU, I was nominated to be involved within the eCTD and xEVMPD working groups, which at the time were run like projects, with fixed face-to-face meetings where the EMA and NCA would share presentations of what had been achieved and status of what was happening. As an observation, I quickly realized the emphasis on the operational deliverables, which could cause challenges in delivering a solution that met visionary goals and considering the ongoing projects within the network.
To go fast, go alone - to go far, go together.
Imagine what could be achieved and then deliver it; guiding principles were crucial to keeping us on the track to success.
- Invest in a strong regulatory network by leveraging technology; this will support connecting to e-Health
- Optimise the regulatory submission process by improving the regulatory assessment and decision making
- Pan-EU collaboration to ensure efficient access to information
- Standardised Global Governance, the transition towards structured data that has the opportunity to communicate globally
- Continue to scan the horizon for future opportunities and challenges
When writing dossiers, technology was something that I just needed to work with; it should work and not be seen. I transitioned to the ISO IDMP task force with an uneasy feeling; instincts kept saying, “here we go again,” but the vision was lost, and collaboration had room for improvement. I was lucky enough to work with some amazing people who knew what was important; we had spoken about it many times. Maybe this time, it would be different; I could step away. I decided to go on a travel sabbatical for five months, optimistic that once I was back, IDMP would be implemented, and we could talk about all those other benefits that could be addressed.
Fast forward seven years, and we are where we are. The vision is a lot clearer than it was all those years ago; we reached our first milestone of the EU IG v2.0 being released.
How?
The EMA created dedicated focus groups comprising ten industry colleagues. It was our responsibility to check the results of public consultations of the initial draft implementation guide and look at the business processes. We worked closely with NCA and EMA representatives to produce a guide that would act as a foundation for the implementation of ISO IDMP in Europe.
We split ourselves into further groups to overcome topics such as how identifiers would work from a technical and business point of view. We continued to open up communication with other experts from other programs (such as Falsified Medicines) to understand their requirements to ensure the collected data worked for the entire network based o the objective to be achieved. This type of work required the ability to dive deep into the details while maintaining an objective overview of everything.
Another topic was to focus on how the submission process would need to be designed in order for the eCTD and PMS data to have a relationship, which relied on the granularity of identifiers and how the PMS identifiers connect to the eCTD UUID. To come up with a solution that could work (still to be tested), it was important to look at what is submitted in an initial MAA and deep dive into the metadata of a submission.
I drew experience from years of lessons learned; my role in Product Management requires me to know what the stakeholders need to reach their objectives. I also have to understand the details of a requirement so I can explain to the technical team possible solutions. The goal of Product Management is to deliver value to our stakeholders while navigating people to a better future.
To many of us, the identifiers were not just unique random numbers consumed by a master data system but the building blocks to connect the network and the patients/health care professional; if implemented correctly, they would continue to add value for decades to come.
Working with EXTEDO has been an eye-opener; I can work for an organization that provides software to over 35 global health authorities, and it is great to be able to share experiences and best practices so that they can save time while creating efficient ways to assess and make a decision on a life-changing medicinal product authorization. I am proud to be able to support industry and agency to drive efficiency and value.
The ISO IDMP implementation within Europe has been released in a stepwise approach; in our webinar, we talk about what is new and how your submission management process will change in the near process. Watch the recording of our webinar: "Discover the mystery around IDMP - what's new in the EU IG v2.0".
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